On June 1, 2023, the EPA issued a final rule to update confidential business information (CBI) requirements under the Toxic Substances Control Act (TSCA) that increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA.

 

“The final rule allows EPA to release non-confidential information more quickly, demonstrating EPA’s ongoing commitment to transparency and data integrity, and makes the process for submitting and substantiating CBI claims more efficient,” states an EPA news release.

“Today’s rule is an important step forward as we work to improve transparency in our chemical safety program,” Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff says in the release. “Putting a process in place to make more health and safety data publicly available more quickly helps give communities the information they need to make informed decisions about the chemicals they’re exposed to.”

Measures to increase transparency

• The Agency made changes to better ensure the existence and scope of a CBI claim are clear and limited to information the submitter views as confidential. The final rule also narrows the types of information in health and safety studies that can be claimed as CBI.  
• For example, the name of the laboratory conducting the study can’t be claimed as CBI unless it would reveal an association with a company whose connection to a chemical is considered CBI.
• The final rule contains a provision to address inappropriate or over-broad CBI claims in public copies of TSCA submissions, especially health- and safety-related information, that specifies a process for the submitter to promptly correct those issues early in the CBI review and that the EPA would promptly deny any remaining inappropriate claims. These changes are expected to remove ambiguity about the scope or validity of claims, permitting more rapid review of valid CBI claims and public access to non-CBI information. The rule doesn’t include the EPA’s proposal to create a new “re-consideration process” in regulation for denied claims, which could have had the unintended result of more requests for reconsideration and associated delays in public access. Instead, the Agency will rely on its existing process.
• Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents like scientific studies, both of which would make more data available to the public more quickly.
• Requirements for electronic communication and maintaining current and accurate contact information will ensure more prompt delivery of required notices to submitters of CBI claims, thereby permitting the EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.
• The final rule also clarifies language included in the proposed rule on how the EPA will handle information used in the TSCA program but obtained under other statutes that also has valid CBI claims under those other statutes. This is to ensure consistency with the Agency’s duty to make information publicly available when it’s legally able to do so.  

For example, data used under TSCA might have originally been submitted under and protected from disclosure under another statute, such as the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA), which prohibits disclosure of certain pesticide data to persons who are acting on behalf of a multinational competitor of the data submitter. The final rule would preserve the protections from disclosure that are required under FIFRA for international trade purposes while maximizing the disclosure of information that can’t be claimed as CBI under TSCA.

Measures to modernize CBI procedures

In an effort to modernize CBI procedures and ensure consistency with TSCA, the EPA is implementing the following:

• Clear and uniform guidance on requirements for assertion and maintenance of CBI claims, including a standard set of substantiation questions used to support a CBI claim;
• Requirements for electronic reporting of virtually all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors the EPA has observed to:
• Better ensure procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names).
• Better and more narrowly articulate the confidential information that’s being claimed.
• Clarify CBI provisions that apply to individual data elements, such as where CBI claims aren’t permitted or where upfront CBI substantiation isn’t required to support a claim.
• Establishment of a new section of the TSCA regulations to centralize and standardize how TSCA CBI claims must be asserted and substantiated; and
• When health and safety information is submitted, requirements that submitters also use an appropriate “Organisation for Economic Co-operation and Development” harmonized template (when available)—a format that will allow data to be more readily used and shared within the Agency while allowing submitters to indicate CBI claims more clearly for EPA consideration.

The final rule becomes effective August 7, 2023.

For more information, see the EPA CBI under TSCA website.